Invest in Monogram Orthopaedics
Linking 3D printing, machine learning, and robotics for high precision implants
Monogram Orthopaedics is offering securities through the use of an Offering Statement that has been qualified by the Securities and Exchange Commission under Tier II of Regulation A. A copy of the Final Offering Circular that forms a part of the Offering Statement may be obtained both here and below. The contents of the Highlights, Term Sheet sections have been prepared by SI Securities, LLC and shall be deemed broker-dealer communications subject to FINRA Rule 2210 (the “Excluded Sections”). With the exception of the Excluded Sections noted above, this profile contains offering materials prepared solely by Monogram Orthopaedics without the assistance of SI Securities, and not subject to FINRA Rule 2210 (the “Issuer Profile”). The Issuer Profile may contain forward-looking statements and information relating to, among other things, the company, its business plan and strategy, and its industry. These statements reflect management’s current views with respect to future events based on information currently available and are subject to risks and uncertainties that could cause the company’s actual results to differ materially. Investors are cautioned not to place undue reliance on these forward-looking statements as they are meant for illustrative purposes and they do not represent guarantees of future results, levels of activity, performance, or achievements, all of which cannot be made. Moreover, no person nor any other person or entity assumes responsibility for the accuracy and completeness of forward-looking statements, and is under no duty to update any such statements to conform them to actual results.
Product & Service
Monogram’s principal advantage over our competition will be our ability to produce customized, robotically inserted orthopaedic implants rapidly and at scale. The product solution architecture that we are developing enables rapid fabrication and mass personalization of robotically inserted, patient specific orthopaedic implants.
The Monogram technology platform – a series of algorithms that auto-segment images and auto-generate implants that will be integrated into a navigated robotic system for surgery – automates the design and insertion of high conforming implants from the raw images using automated digital image analysis algorithms. The navigated robot will then execute optimized auto-generated cut paths that surgically prepare the corresponding cavities to facilitate insertion of the implant.
We believe that Monogram’s navigated robot features several enhancements that will improve the user experience as compared to the current robots in use. Specifically, the Monogram robot will feature tracking cameras that are mounted directly to the robot to mitigate line-of-sight issues. The robot will feature seven degrees-of-freedom (used to measure range of motion) with control algorithms that leverage the kinematic redundancy to avoid interoperative boundaries and optimize the surgical execution. The robot will also utilize complex tracking capabilities for soft-tissue avoidance.
For the patient specific implants, it is generally understood that a tight fit and ease of insertion can be conflicting requirements for a viable implant. The Monogram implants are designed such that cortical contact, and therefore stability, are maximized while remaining insertable. The Monogram implants are designed to reconstruct the native patient anatomy as closely as possible. Monogram will first commercialize a patient specific hip and patient specific knee that will address the primary clinical shortcomings of their generic counterparts.
With generic implants in hips for example, manual bone preparation can contribute to periprosthetic fracture, dislocation, leg length inequality, subsidence and early loosening, and suboptimal function outcomes. With generic knee implants aseptic loosening of the tibial component and malalignment are major reasons for failure. Current hip stems have very limited options to restore anatomy. For example, most implants are available in only two widths despite wide human anatomic variations. They are geometric as opposed to organic in shape, which limits the amount of direct bone contact required for initial stability and long-term biological fixation. For generic knee implants, we believe the general design premise of a flat resection plane for the tibial component is flawed.
Monogram is designing additively manufactured (AM) patient matched titanium hip stems and tibial knee implants that will require robotically milled complementary cavities. Our monetizatible products will include:
Surgical robotic system
Cutting tools and navigation consumables
Software licensing of clinical modules
Patient specific reconstructive implants
Monogram was started by Dr. Douglas Unis, an attending orthopaedic surgeon for the Mount Sinai Health System, in 2016 after being awarded a $30k grant from the prestigious ELabNYC biotech startup incubator. Dr. Unis has a deep passion for patient well-being. After years of consulting with several strategic companies, Dr. Unis grew frustrated by the slow pace of innovation and a lack of focus on implant design. Dr. Unis realized that the surgical readmissions and implant failures were only in part driven by the surgical method. The implants themselves had significant design limitations that could be vastly improved with new manufacturing methods and robotic insertion.
With an unassailable belief that the answer lies in in the thoughtful synthesis of machine learning (AI), robotics, and 3D printing, Dr. Unis recruited a team of highly energized engineers, medtech, and entrepreneurs to realize his vision.
Founders and Officers
Q&A with the Founder
Please detail the current stage of your product/platform development.
Monogram currently has a functioning prototype that successfully autogenerated five patient specific implants from a simulated specimen, autogenerated the robotic cut paths, and high-precision milled the cavities for each specimen for micromotion testing. The implant prototype specimens were tested against five manually inserted conventional implants to determine relative performance. The data validated superior placement of the anatomical center of rotation, higher surface area contact and significantly decreased micromotion.
More specifically, our prototype consists of image processing and implant & cut path generation algorithms with a surgeon interface GUI. These algorithms interface with our robotic system which consists of a registration protocol, a real time camera tracking system, a milling end-effector and an activation handle. Our robot is able to mill the implant cavities from the cut-paths autogenerated by our algorithm.
The end-result is a stable implant that restores the native anatomy. This is optimal for active patients with a desire to continue their sporting activities.
Please describe your typical customer/user profile.
Our average customer is 65 years old with arthritis. For the average patient, the time between the onset of pain and surgery is significant, often several years or even a decade. This is especially true for patients that are active and enjoy activities like hiking, golfing, tennis, etc., the fear of no longer being active is significant. With new materials for example, cross-linked polyethylene liners and ceramic balls last much longer. This has expanded the addressable patient pool to younger and younger patients. These are ideal candidates for our procedure.
Who do you view as your closest competitors and what key factors differentiate yourselves?
For our primary market of entry, hip replacements, we only see one major competitor, Mako Surgical. The Mako robot does not do any femoral milling, it is doing acetabular reaming only. So, effectively our largest competitor is executing only ~50% of the procedure. In addition, the Mako system relies on generic, geometric standard implants, they use no customization or differentiation. Notably, there are no patient specific hips that are implanted with a surgical robot. There are companies in the space with elements of our system, but the comprehensive solution is a greenfield opportunity and we believe will be highly disruptive.
Please outline the regulatory landscape of your market, any regulations you must comply with, and how you comply with those regulations, if applicable.
The market for our products is regulated by the FDA. There are well defined ISO standards for the commercialization of these technologies. Our system will be going through the 510(k) approval process. We will be claiming substantial equivalency to approved and marketed devices. We have began discussions to develop and substantiate this plan with the Musculoskeletal Clinical Regulatory Advisers (MCRA), a prestigious regulatory consultancy for orthopedic technologies.
Please outline your customer acquisition strategy.
Our product launch will consist of two phases, with Phase I representing the strategic markets launch and Phase II consisting of the growth capital, clinical trial, and market penetration. In Phase I, our goal is to achieve revenue of $10m with tactical large hospital penetration through the strategic relationships of our founders.
Post placement of our initial robots, the strategy is to raise strategic growth capital that will facilitate more rapid growth. This growth will be a mix of in house and independent sales representatives. Comparable company analysis with Mako Surgical helps validate a market premium for FDA approved, differentiated products generating revenue. At the time of their IPO, Mako was generating $1.9m of revenue and raised $51m in an IPO with a valuation of $180m.
Notably, the Phase I and Phase II launches will have custom pricing models for the hardware. We believe a single robot will be able generate $5-10m of recurring revenue and recover it’s placement cost within months. To facilitate early market penetration, we are exploring discounted placement of the robot at little to no cost for key high-volume accounts.
The Q&A with the Founder is based on due diligence activities conducted by SI Securities, LLC. The verbal and/or written responses transcribed above may have been modified to address grammatical, typographical, or factual errors, or by special request of the company to protect confidential information.